Label: COOLA MINERAL LIPLUX LIP BALM SPF 30 SKINNY DIP- zinc oxide stick
- NDC Code(s): 79753-056-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 2, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating.
- Apply at least every 2 hours.
- Sun Protection Measures - To decrease your risk of cancer and early skin aging, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.
-
INACTIVE INGREDIENT
Acacia Decurrens Flower Wax, Butyrospermum Parkii (ORGANIC Shea Butter), C18-38 Alkyl Hydroxystearoyl Stearate, Caesalpinia
Sappan Bark Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Flavor, Helianthus
Annuus (ORGANIC Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Iron Oxides, Hydrogenated Castor Oil, Jojoba
Esters, Mica, Octyldodecyl Oleate, Octyldodecyl PCA, Olea Europaea (ORGANIC Olive) Fruit Oil, Persea Gratissima (ORGANIC
Avocado) Oil, Polyglycerin-3, Polyhydroxystearic Acid, Rosmarinus Officinalis (ORGANIC Rosemary) Leaf Extract, Schinziophyton
Rautanenii Kernel Oil (ORGANIC), Silica, Stevia Rebaudiana Extract, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Theobroma
Grandiflorum Seed Butter (ORGANIC), Tin Oxide - OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COOLA MINERAL LIPLUX LIP BALM SPF 30 SKINNY DIP
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.6 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g in 100 g Inactive Ingredients Ingredient Name Strength OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) STANNIC OXIDE (UNII: KM7N50LOS6) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) OCTYLDODECYL PCA (UNII: E25TY46YTD) FERRIC OXIDE RED (UNII: 1K09F3G675) COCONUT OIL (UNII: Q9L0O73W7L) CARNAUBA WAX (UNII: R12CBM0EIZ) AVOCADO OIL (UNII: 6VNO72PFC1) COCOA BUTTER (UNII: 512OYT1CRR) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ROSEMARY (UNII: IJ67X351P9) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SUNFLOWER OIL (UNII: 3W1JG795YI) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2) CAESALPINIA SAPPAN BARK (UNII: R6995U1QSX) FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-056-01 1 in 1 CARTON 02/01/2019 1 4.2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2019 Labeler - COOLA, LLC (956990290)
